Help patients get started on ORILISSA
Get help with prior authorization requests
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Downloadable resources for your office
Along with support from CoverMyMeds, you can download the instructions and templates below for helpful guidelines and tips for navigating the prior authorization process.
This information is for informational purposes only and is not intended to provide reimbursement or legal advice. The information presented here does not guarantee payment or coverage.
*Terms and Conditions apply. This benefit covers ORILISSA® (elagolix). Eligibility: Available to patients with commercial insurance coverage for ORILISSA who meet eligibility criteria. Co-pay assistance program is not available to patients receiving reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving drug coverage under any such federal, state, or government-funded healthcare program, patient will no longer be able to use the ORILISSA Savings Card and patient must call 1-800-ORILISSA (1-800-674-5477) to stop participation. Patients residing in or receiving treatment in certain states may not be eligible. Patients may not seek reimbursement for value received from the ORILISSA Savings Card Program from any third-party payers. Offer subject to change or discontinuation without notice. Restrictions, including monthly maximums, may apply. Subject to all other terms and conditions, the maximum annual benefit that may be available solely for the patient’s benefit under the co-pay assistance program is $5,000 per calendar year. The actual application and use of the benefit available under the co-pay assistance program may vary on a monthly, quarterly, and/or annual basis depending on each individual patient’s plan of insurance and other prescription drug costs. This assistance offer is not health insurance. By redeeming this card, you acknowledge that you are an eligible patient and that you understand and agree to comply with the terms and conditions of this offer. To learn about AbbVie’s privacy practices and your privacy choices, visit https://privacy.abbvie
Indication and Important Safety Information
ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis.
IMPORTANT SAFETY INFORMATION1
- ORILISSA is contraindicated in women who are pregnant (exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss), in women with known osteoporosis or severe hepatic impairment, or with concomitant use of strong organic anion transporting polypeptide (OATP) 1B1 inhibitors (e.g., cyclosporine and gemfibrozil).
WARNINGS AND PRECAUTIONS
- ORILISSA causes a dose-dependent decrease in bone mineral density (BMD), which is greater with increasing duration of use and may not be completely reversible after stopping treatment.
- The impact of ORILISSA-associated decreases in BMD on long-term bone health and future fracture risk is unknown. Consider assessment of BMD in patients with a history of low-trauma fracture or other risk factors for osteoporosis or bone loss, and do not use in women with known osteoporosis.
- Limit the duration of use to reduce the extent of bone loss.
Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy
- Women who take ORILISSA may experience a reduction in the amount, intensity, or duration of menstrual bleeding, which may reduce the ability to recognize the occurrence of pregnancy in a timely manner. Perform pregnancy testing if pregnancy is suspected, and discontinue ORILISSA if pregnancy is confirmed.
Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders
- Suicidal ideation and behavior, including one completed suicide, occurred in subjects treated with ORILISSA in the endometriosis clinical trials.
- ORILISSA users had a higher incidence of depression and mood changes compared to placebo and ORILISSA users with a history of suicidality or depression had an increased incidence of depression. Promptly evaluate patients with depressive symptoms to determine whether the risks of continued therapy outweigh the benefits. Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate.
- Advise patients to seek immediate medical attention for suicidal ideation and behavior. Reevaluate the benefits and risks of continuing ORILISSA if such events occur.
Hepatic Transaminase Elevations
- In clinical trials, dose-dependent elevations of serum alanine aminotransferase (ALT) at least 3 times the upper limit of the reference range occurred with ORILISSA.
- Use the lowest effective dose and instruct patients to promptly seek medical attention in case of symptoms or signs that may reflect liver injury, such as jaundice.
- Promptly evaluate patients with elevations in liver tests to determine whether the benefits of continued therapy outweigh the risks.
Reduced Efficacy with Estrogen-Containing Contraceptives
- Based on the mechanism of action of ORILISSA, estrogen-containing contraceptives are expected to reduce the efficacy of ORILISSA. The effect of progestin-only contraceptives on the efficacy of ORILISSA is unknown.
- Advise women to use non-hormonal contraceptives during treatment and for one week after discontinuing ORILISSA.
- The most common adverse reactions (>5%) in clinical trials included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions, and mood changes.
These are not all the possible side effects of ORILISSA.
Safety and effectiveness of ORILISSA in patients less than 18 years of age have not been established.
For more information, please click here for full Prescribing Information.
1. ORILISSA [package insert]. North Chicago, IL: AbbVie Inc.